The Kerala High court has stayed a recent order of the state drug controller to withdraw the restrictions related to distance factor on sanctioning new medical shops.

The state drug controller had withdrawn the restrictions during the second week of December 2004, following a directive from the state health minister K K Ramachandran, as reported by Pharmbiz earlier. Kerala is the first state in the country to impose distance factor in restricting mushrooming of medical shops.

A few days ago, the Kerala High Court's single bench of Justice Joseph accepted a joint petition filed by A Vinod, of New Sakthi Medicals, Chellakkara and the All Kerala Chemists and Druggists Association (AKCDA). The court accepted the petition and awarded an interim stay for two weeks, and notices were served to the government departments concerned to respond within the timeframe.

The petitioner, a pharmacist, contended he had become an aggrieved party by the order. AKCDA informed the court that being the party likely to be affected by the decision, the government had not consulted them while implementing the decision, and hence the order should be cancelled.

Talking to Pharmabiz, T P Gopinath, drug controller, Kerala said the government would soon respond to the court. The DC also said the department had also withdrawn the ruling on doing away restrictions related to minimum area requirements for sanctioning new medical shops.

Meanwhile, sources said about 100 medical shops have been sanctioned by the drug control department in the last two months, since the restrictions, were withdrawn by the department.

As per an order issued in December 2002, the Kerala drug control department had decided not to allow any new retail outlets within a vicinity of at least 100 metres away from the existing chemist shops in the case of rural area and 50 metres in urban area. Further, the circular had mandated to have a minimum area of 15 sq.metres for retail outlets and 20 sq.metre space for wholesale outlets, instead of the 10 sq.metres provision prescribed in the Drugs & Cosmetics Act, 1940. This was introduced with a view to regulate proliferation of medical outlets and unethical drug trade, and due to complaints from traders on unethical competition from nearby medical stores. The DC enforced these provisions as per the powers conferred on him as per Rules 64 (1) and (2) of the Drugs & Cosmetics Act, 1940.

However, both the provisions were withdrawn as per a circular dated December 9, 2004, following a directive from the state health minister K K Ramachandran. The minister said many MLAs were demanding to scrap these provisions for sometime as many people were complaining the clauses caused difficulties in approving new medical shops. Further, the restrictions would deny numerous jobless people in the state an opportunity to start medical shops for living, the minister had reasoned, earlier.